nanocross btk, a prospective, non-randomized, multicenter, controlled trial evaluating the performance of the nanocrosstm .014 balloon catheter in infrapopliteal lesions

Conditions: Peripheral Arterial Disease

Summary: the objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of nanocrosstm balloon catheter (covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the level of the below-the-knee arteries.


Eligibility criteria:
inclusion criteria: * patient presenting with rest pain or minor tissue loss (rutherford class 4 or 5) * patient is willing to comply with specified follow-up evaluations at the specified times * patient is \>18 years old * patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * patient has a projected life-expectancy of at least 12 months * patient is eligible for treatment with the nanocrosstm .014 balloon catheter (covidien) * male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure * de novo lesion or restenotic lesion after pta in the infrapopliteal arteries,suitable for endovascular therapy * total target lesion length minimally 100mm * target vessel diameter visually estimated to be \>1.5mm and \<4.0mm * guidewire and delivery system successfully traversed lesion * at least one non-occluded crural artery with angiographically documented run- off to the foot. exclusion criteria: * patient refusing treatment * the reference segment diameter is not suitable for the available balloon design * untreated flow-limiting inflow lesions * perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment * any previous surgery in the target vessel (including prior ipsilateral crural bypass) * aneurysm in the target vessel * target lesion has severe calcification as determined by physician's discretion * non-atherosclerotic disease resulting in occlusion (e.g. embolism, buerger's disease, vasculitis) * severe medical comorbidities (untreated cad/chf, severe copd, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy * major distal amputation (above the transmetatarsal) in the study limb or non- study limb * septicemia or bacteremia * any previously known coagulation disorder, including hypercoagulability * contraindication to anticoagulation or antiplatelet therapy * known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure * patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (hit) type ii * currently participating in another clinical research trial * angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment * target lesion access not performed by transfemoral approach.

Keywords: peripheral arterial disease infrapopliteal lesions balloon catheter